(a) Field of the Invention
This invention relates to a novel therapeutic form of spray dried ibuprofen having a neutral taste which can be formulated into, for example, chewable tablets and fast dissolving dosage forms as described in U.S. Pat. Nos. 4,305,502 and 4,371,516. More specifically this invention relates to a taste-neutral spray dried powder formed by spray drying a solution of ibuprofen and cellulose acetate phthalate in a mixture of a lower alkanol and ethyl acetate having suspended therein colloidal silica or montmorillonite clay. By taste-neutral it is meant that the powder has essentially no taste and is neither sweet nor bitter.
(b) Prior Art
Ibuprofen, a widely used analgesic and antipyretic, is not palatable enough to be used in chew-type tablets for those people who do not swallow whole solid-type dosage forms.
The use of flavor agents eg. chocolate, banana, orange, lemon, licorice, root beer, and raspberry, in particular, have been proposed for bitter tasting drugs. These agents are not dependable masking ingredients. Mint flavors can be useful in ameliorating a chalky taste parameter. Bitter properties, however, are very difficult to mask to any great extent, particularly, when they do not mimic the expected natural taste of the flavor agent.
Other properties ncluding mouthfeel also need to be addressed in consideration of the oral acceptance of chewable or chew-type tablets.
The fast dissolving dosage forms described in U.S. Pat. Nos. 4,305,502 and 4,371,516 are manufactured to disintegrate in water within five seconds or less and hence dissolve rapidly in the saliva of the mouth. Heretofore the use of such dosage forms were restricted to pharmaceuticals which had a neutral taste or a slightly disagreeable taste which could be masked by a flavoring agent. Pharmaceuticals with a bitter taste such as ibuprofen are not currently used in such dosage forms.